510(k) · Cleared
ClearedMilagro Interference Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Mitek, A Johnson & Johnson Company · HWC Screw, Fixation, Bone
Cleared on Jun 15, 2006 as substantially equivalent to K032717 (Mitek Worldwide, 2004) and 1 other predicate after an 80-day review. Its family tree reaches back 5 generations to 1997. 103 later devices descend from it.
- Decided
- Jun 15, 2006
- Review
- 80 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K971358 (1997). 8 ancestors in all. 103 later devices descend from it, 10 citing it directly.
- Root · 5 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 4 generations backK990454 Bio-Interference ScrewInnovasive Devices, Inc. · 1999
- 3 generations backK993975 Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999
- 2 generations backK013572 Mitek Biocryl Interference ScrewsMitek Products · 2002
- 1 generation backK032717 Biocryl Rapide Interference ScrewMitek Worldwide · 2004
- This deviceK060830 Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2006
- Descendant · cites it directly · 47 of its ownK071176 Modification to: Arthrex Interference ScrewArthrex, Inc. · 2007
- Descendant · cites it directly · 44 of its ownK073412 Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company · 2008 · Recalled
- Descendant · 2 generations on · 38 of its ownK151342 Arthrex SwiveLock AnchorsArthrex, Inc. · 2016
- Descendant · 3 generations on · 29 of its ownK171141 Arthrex SwiveLock AnchorsArthrex, Inc. · 2017
- Descendant · 3 generations on · 28 of its ownK180768 Arthrex SwiveLock AnchorsArthrex, Inc. · 2018
Showing 5 of 103 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 103 · See all- K071176Modification to: Arthrex Interference ScrewArthrex, Inc. · 2007 · cites it directly47descendants
- K073412Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company · 2008 · cites it directly44descendants
- K151342Arthrex SwiveLock AnchorsArthrex, Inc. · 2016 · 2 generations on38descendants
- K171141Arthrex SwiveLock AnchorsArthrex, Inc. · 2017 · 3 generations on29descendants
- K180768Arthrex SwiveLock AnchorsArthrex, Inc. · 2018 · 3 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K971358 | Bio-Interference Screw, 7 MM, 8 MM, 9 MM | Arthrex, Inc. | 1997 | — |
| −4 | K990454 | Bio-Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −3 | K993975 | Absolute Absorbable Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −2 | K013572 | Mitek Biocryl Interference Screws | Mitek Products | 2002 | — |
| −1 | K032717 | Biocryl Rapide Interference Screw | Mitek Worldwide | 2004 | — |
| 0 (this device) | K060830 | Milagro Interference Screw | Depuy Mitek, A Johnson & Johnson Company | 2006 | — |
| +1 | K071176 | Modification to: Arthrex Interference Screw | Arthrex, Inc. | 2007 | — |
| +1 | K073412 | Gryphon BR and Healix BR Anchors | Depuy Mitek, A Johnson & Johnson Company | 2008 | 1 |
| +2 | K151342 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2016 | — |
| +3 | K171141 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2017 | — |
| +3 | K180768 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 6 | 0 |
| 2012 | 3 | 0 |
| 2013 | 7 | 0 |
| 2014 | 4 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2018 | 7 | 0 |
| 2019 | 8 | 0 |
| 2020 | 5 | 0 |
| 2021 | 7 | 0 |
| 2022 | 5 | 0 |
| 2023 | 11 | 0 |
| 2024 | 7 | 0 |
| 2025 | 10 | 0 |
| 2026 | 9 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HWC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032717 | Biocryl Rapide Interference ScrewSummary page 2…ied lengths. Substantial Equivalence The MILAGRO Interference Screw is a commercially marketed device that was subject of K032717 (cleared March 31, 2004). When used for the proposed indications the device is substantially e… | 2004 |
| * | K003227 | Bio-Absorbable Corkscrew Model AR-1920BSummary page 2…the proposed indications the device is substantially equivalent to the Arthrex Bio-Corkscrew Suture Anchor (K003227, cleared 1/8/2001). Safety and Performance The determination of substantial equivalence for this device was based… | 2001 |
What descends from it? (103)
See all 10310 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071176 | Modification to: Arthrex Interference Screw | 2007 | 47 |
| K073412 | Gryphon BR and Healix BR Anchors | 2008 | 44 |
| K103831 | Depuy Mitek Milagro Interference Screw Model 231803, 231804, 231807, 231809 | 2011 | 18 |
| K112249 | Healix Knotless (TM) Anchor | 2011 | 13 |
| K123362 | Milagro Advance Interference Screw | 2013 | 5 |
| K102410 | Matryx Interference Screw (5.0-6.5MM) | 2010 | 2 |
| K120589 | Milagro Interference Screws | 2012 | 1 |
| K071437 | Megafix-C Bioabsorbable Composite Interference Screw, Model 2870719C, 2870723C… | 2007 | 1 |
| K161174 | Nanova Interference Screw | 2016 | 0 |
| K122869 | Milagro Interference Screws | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K071176 (Arthrex, Inc., 2007) has gone furthest, with 47 descendants of its own.
- 8 other devices also cite its predicate K032717.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The MILAGRO Interference Screw is indicated for the fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee. Additionally, the 7, 8 and 9 mm x 23 mm screws will be indicated for: medial and lateral collateral ligament repair of the knee, proximal bicep tenodesis in the shoulder and distal bicep tenodesis in the elbow.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060830 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060830: Milagro Interference Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060830
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026